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26828 Diabetes Autoimmune Profile (FDAIP)

Diabetes Autoimmune Profile (FDAIP)
Test Code: FDAIPSO
Synonyms/Keywords

Insulin Antibodies

Anti GAD 65 Antibodies

IA-2 Autoantibodies

ZNT8 Antibodies

Type 1 Diabetes​​

Useful For

​Diabetes autoantibodies assessment is helpful in identifying and managing patients at risk for development of type 1 diabetes.​

Specimen Requirements
Specimen Type
Preferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)		Pediatric Minimum Volume
(no repeat)
​Serum
​Serum Separator Tube (STT)
​Red Top Tube (RTT)​
​2.5 mL
​2.0 mL​
​​1.0 mL
Collection Processing Instructions

​Collection Instructions: 

1. Centrifuge and aliquot 2.5 mL of serum into a plastic vial. 

2. Freeze immediately and send frozen.

Specimen Stability Information
Specimen Type

TemperatureTime
​Serum
​Frozen​
​7 days
Rejection Criteria

​Gross hemolysis

Thawing:  Cold ok; Warm reject

Lipemia

EDTA plasma

Performing Laboratory Information
Performing Location
Day(s) Test PerformedAnalytical TimeMethodology/Instrumentation

200 1st St. SW

Rochester, MN 55905

**Mayo forwards to Esoterix Endocrinology**

​​Varies
​10 to 19 days
​Enzyme-linked immunosorbent assay (ELISA), radioimmunoprecipitation
Reference Lab
Mayo Clinic Laboratories
Test Information
This test was developed and its performance characteristics determined by LabCorp.  It has not been cleared or approved by the US Food and Drug Administration.  This test is used for clinical purposes.  It should not be regarded as investigational or for research.

Published positivity rates for diabetes autoantibodies in new-onset Type 1 diabetes patients listed below are based on the combined analysis of GAD-65, ICA 512, insulin antibodies, and ZNT8 antibodies. The combined analysis has a 98% autoimmunity detection rate, with 1.8% of Type 1 diabetic individuals remaining as autoantibody-negative.

 

Positive rate in new-onset type 1 diabetes patients:

GAD-65 antibodies = 68% positive

ICA 512 antibodies = 72% positive

Insulin antibodies = 55% positive

ZnT8 antibodies = 63% positive

 

An increase in the number of positive antibodies is associated with a higher likelihood of type 1 diabetes. Less than 3% of Type 2 diabetics have positive antibodies.​​​

Reference Range Information

Insulin Antibodies

<5.0 uU/mL: Negative

>=5.0 uU/mL:  Positive

 

Anti GAD 65 Antibodies

<5.0 U/mL: Negative

>=5.0 U/mL:  Positive

 

IA-2 Autoantibodies

<7.5 U/mL: Negative

> =7.5 U/mL:  Positive

 

ZNT8 Antibodies

<15 U/mL: Negative

> =15 U/mL:  Positive 

Reference ranges apply to all ages.


Outreach CPTs
CPT

Modifier
(if needed)		QuantityDescriptionComments
86337
​​1
​​
​​86341
​​3
​​
Classification
This test was developed and its performance characteristics determined by Marshfield Labs.  It has not been cleared or approved by the US Food and Drug Administration.  This test is used for clinical purposes.  It should not be regarded as investigational or for research.

​​

Synonyms/Keywords

Insulin Antibodies

Anti GAD 65 Antibodies

IA-2 Autoantibodies

ZNT8 Antibodies

Type 1 Diabetes​​

Ordering Applications
Ordering ApplicationDescription
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen Type
Preferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)		Pediatric Minimum Volume
(no repeat)
​Serum
​Serum Separator Tube (STT)
​Red Top Tube (RTT)​
​2.5 mL
​2.0 mL​
​​1.0 mL
Collection Processing

​Collection Instructions: 

1. Centrifuge and aliquot 2.5 mL of serum into a plastic vial. 

2. Freeze immediately and send frozen.

Specimen Stability Information
Specimen Type

TemperatureTime
​Serum
​Frozen​
​7 days
Rejection Criteria

​Gross hemolysis

Thawing:  Cold ok; Warm reject

Lipemia

EDTA plasma

Useful For

​Diabetes autoantibodies assessment is helpful in identifying and managing patients at risk for development of type 1 diabetes.​

Reference Range Information

Insulin Antibodies

<5.0 uU/mL: Negative

>=5.0 uU/mL:  Positive

 

Anti GAD 65 Antibodies

<5.0 U/mL: Negative

>=5.0 U/mL:  Positive

 

IA-2 Autoantibodies

<7.5 U/mL: Negative

> =7.5 U/mL:  Positive

 

ZNT8 Antibodies

<15 U/mL: Negative

> =15 U/mL:  Positive 

Reference ranges apply to all ages.


For more information visit:
Performing Laboratory Information
Performing Location
Day(s) Test PerformedAnalytical TimeMethodology/Instrumentation

200 1st St. SW

Rochester, MN 55905

**Mayo forwards to Esoterix Endocrinology**

​​Varies
​10 to 19 days
​Enzyme-linked immunosorbent assay (ELISA), radioimmunoprecipitation
Reference Lab
Mayo Clinic Laboratories
For billing questions, see Contacts
Outreach CPTs
CPT

Modifier
(if needed)		QuantityDescriptionComments
86337
​​1
​​
​​86341
​​3
​​
Classification
This test was developed and its performance characteristics determined by Marshfield Labs.  It has not been cleared or approved by the US Food and Drug Administration.  This test is used for clinical purposes.  It should not be regarded as investigational or for research.

​​

For most current information refer to the Marshfield Laboratory online reference manual.